Dri-Dye Check Strips (TM)-405
FDA 510(k) K892656 · Awareness Technology, Inc.
510(k) numberK892656
Submission
- Device name
- Dri-Dye Check Strips (TM)-405
- Applicant
- Awareness Technology, Inc.
Palm City, FL, US - Received
- April 13, 1989
- Decision date
- May 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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Questions and answers
When was Dri-Dye Check Strips (TM)-405 cleared by the FDA?
Dri-Dye Check Strips (TM)-405 (K892656) received a 510(k) decision of Substantially Equivalent on May 22, 1989, 39 days after the submission was received.
What is the product code of K892656?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.